DETAILED ACTION
Claims 1-2 and 5-22 are pending and the subject of the Office Action below.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 22 has inadvertently been numbered 21, giving two claim 21’s. The second claim 21 will be considered 22 for Examination.
Election/Restrictions
Applicant’s election without traverse of Group V (drawn to a method of treating a hematological cancer comprising administering a PRMT9 inhibitor that is a small molecule compound), in the Reply filed on 4/27/2026, is acknowledged.
Applicant states, claims 1, 2, and 6-22 read on elected Group V.
Claim 5 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the Reply.
Applicant’s election of species without traverse of the compound:
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in the Reply filed on 4/27/2026, is acknowledged.
Only claims 1-2 read on the claimed compound, while claims 8 and 19 are directed to this compound specifically, this compound lacks antecedent basis from the generic/Markush structure of claims 6 and 14. The generic/Markush structure requires that the R4 group be present in n amount, which is an integer from 1 to 4. In the elected species the integer of 0 is required for n (which is not allowed). As such the elected species can not be derived from the genus/Markush genus. Since R4 group cannot be a hydrogen, and the R4 group must be present, the Markush group is improper as to the elected species.
The elected species is free from the prior art and would be allowable in either a method claim of composition claim. The MPEP requires when the elected species is free from the prior art, the Examiner is to extend the search to the Markush Claim, if proper. In this case the Markush claim is not proper. As such the Examiner moved to the next proper species to continue the search:
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Claims 1, 2, and 22 read on this species and are present for Examination and the subject of the Office Action below.
The requirement is still deemed proper and is therefore made FINAL.
Priority
The instant application filed 10/6/2023 Claims Priority from Provisional Application 63378798, filed 10/7/2022.
Information Disclosure Statement
The Information Disclosure Statements (IDS) submitted on 5/29/2024 and 3/12/2026, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the Information Disclosure Statements are being considered by the Examiner.
Claim Rejections - 35 USC § 112(a)
Written Description
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 2 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the claimed “a protein arginine methyltransferase 9 inhibitor” is a purely functional recitation with no limitation of structure.
MPEP 2173.05(g) discusses the treatment of functional language. In this case, because the language is directed to function alone, and Applicant is not modifying any structure, the claim should use “means for” language. Since Applicant has not used “means for language,” the MPEP states:
Indefiniteness: use of functional language in a claim may fail "to provide a clear-cut indication of the scope of the subject matter embraced by the claim" and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. While the claim here is broad, one would understand that Applicant is claiming “all pharmaceuticals” that include is a short-hairpin RNA, a small interference RNA, a piwi-interacting RNA, a microRNA, a CRISPR Cas guide RNA, an antisense oligonucleotide, a small molecule compound, or an anti- PRMT9 antibody. So while the claim is EXTREMLEY broad, the claim is not indefinite. This is the case because the claim is directed to a “method of treating” and not to a composition of matter. A claim directed to “a composition comprising a protein arginine methyltransferase 9 inhibitor,” would be indefinite.
Written Description: Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). See also Datamize LLC v. Plumtree Software Inc., 417 F.3d 1342, 75 USPQ2d 1801 (Fed. Cir. 2005) where a claim directed to a software based system for creating a customized computer interface screen recited that the screen be "aesthetically pleasing," which is an intended result and does not provide a clear cut indication of scope because it imposed no structural limits on the screen. Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167. For instance, a single means claim covering every conceivable means for achieving the stated result was held to be invalid under 35 U.S.C. 112, first paragraph because the court recognized that the specification, which disclosed only those means known to the inventor, was not commensurate in scope with the claim.
This is the case here, and therefore the instant claims are rejected for lack of written description as discussed below.
Applicant appears to be using a “means for” type claiming without the recitation of “means”..... Applicant's claim reads as a "means for inhibiting protein arginine methyltransferase 9 .”
When a claim uses the term “means” to describe a limitation, a presumption inheres that the inventor used the term to invoke § 112, ¶ 6. Altiris, Inc. v. Symantec Corp., 318 F.3d 1363, 1375 (Fed. Cir. 2003). “This presumption can be rebutted when the claim, in addition to the functional language, recites structure sufficient to perform the claimed function in its entirety.” Id.
As the court set forth in LG Electronics:
" '[A] claim term that does not use 'means' will trigger the rebuttable presumption that § 112 ¶ 6 does not apply.' " Lighting World, Inc. v. Birchwood Lighting, Inc., 382 F.3d 1354, 1358 (Fed. Cir. 2004) (quoting CCS Fitness, Inc. v. Brunswick Corp., 288 F.3d 1359, 1369 (Fed. Cir. 2002)). This presumption can be rebutted "by showing that the claim element recite[s] a function without reciting sufficient structure for performing that function." Watts v. XL Sys., 232 F.3d 877, 880 (Fed. Cir. 2000) (citing Rodime PLC v. Seagate Tech., Inc., 174 F.3d 1294, 1302 (Fed. Cir. 1999)). However, the presumption "is a strong one that is not readily overcome." Lighting World, Inc., 382 F.3d at 1358.
LG Electronics, Inc. v. Bizcom Electronics, Inc., 453 F.3d 1364, 1372
(Fed. Cir. 2006).
Because the Applicant did not use “means” to recite the limitation (“a protein arginine methyltransferase 9 inhibitor”) in claim 1, the presumption is that the Applicant did not intend to invoke interpretation of “a protein arginine methyltransferase 9 inhibitor” under § 112, sixth paragraph.
Applicant is reminded that 35 U.S.C. § 112, sixth paragraph, when enacted, was a statutory response to the Supreme Court’s decision in Halliburton Oil Well Cementing Co. v. Walker, 329 U.S. 1 (1946).
This general prohibition against the use of “purely functional claim language” (and the more specific Halliburton rule) has not been completely eliminated. Rather, “purely functional claim language” is now permissible but only under the conditions of 35 U.S.C. § 112, sixth paragraph, i.e., if its scope is limited to the corresponding structure, material, or act disclosed in the specification and equivalents thereof.
In the absence of such limited construction, the concerns expressed by the Court in Halliburton are still applicable to prohibit the use of “purely functional” claim language. Hence, any claim that includes purely functional claim language, and which is not subject to the limited construction under 35 U.S.C. § 112, sixth paragraph, fails to meet the requirements of 35 U.S.C. § 112, first paragraph, according to reasoning in Halliburton and thus is unpatentable.
While the particular claim language involved in the Supreme Court's Halliburton decision uses the word “means,” the issue was claiming in a purely functional manner, a practice condemned by pre-existing case law, and not any particular problem associated uniquely with the word “means” as distinguished from other purely functional words and phrases. With regard to pre-existing case law around the time of the Supreme Court's Halliburton decision, see In re Fuetterer, 319 F.2d 259, 263 (CCPA 1963), wherein the Court of Customs and Patent Appeals explained:
In the Fullam case [In re Fullam, 161 F.2d 247 (CCPA 1947)], this court stated that some claims were properly rejected as “functional in claiming merely the desired result well known to and sought after by workers skilled in the art.” Claims directed merely to a “desired result” have long been considered objectionable primarily because they cover any means which anyone may ever discover of producing the result. See, e.g., O'Reilly v. Morse, 15 How. 62; Heidbrink v. McKesson, 290 F. 665.
The Supreme Court’s Halliburton case remains viable for claims having purely functional claim language which is unlimited either by (1) the application of 35 U.S.C. § 112, sixth paragraph, or (2) the additional recitation of structure.
In the present case, claim 1, which recites “a protein arginine methyltransferase 9 inhibitor” violates the rule set forth in Halliburton, because the claims are not limited by the application of 35 U.S.C. § 112, sixth paragraph, and they do not contain any additional recitation of structure. As such, these claims are unpatentable under 35 U.S.C. § 112, first paragraph, for lack of written description.
In this case Applicant is in possession of a small group of small molecule inhibitors described in Claims 6-9 (in methods) and Claims 14-18 and 21 (compound claims) that are described in the Specification and Claims.
Applicant has not described any structures having protein arginine methyltransferase 9 inhibition: a short-hairpin RNA, a small interference RNA, a piwi-interacting RNA, a microRNA, a CRISPR Cas guide RNA, an antisense oligonucleotide, and an anti-PRMT9 antibody. There is no disclosure of any structure having the function, as such Applicant lacks written description of these compounds.
Applicant has not described enough distinct classes of “small molecule compounds” that inhibit protein arginine methyltransferase 9 to claim all and any structure that is a “small molecule” with this function. Therefore Applicant has not described other compounds that have the function, to claim the entire genus of “small molecules.”
Claims 1-2 are rejected under 112(a).
In further discussion of claim 2. Claim 2 states, “a short-hairpin RNA, a small interference RNA, a piwi-interacting RNA, a microRNA, a CRISPR Cas guide RNA, an antisense oligonucleotide, a small molecule compound, or an anti- PRMT9 antibody.” Or in claim 5, “an anti-di-methylated poly (A) binding protein cytoplasmic 1 antibody.” These recitations lack written description.
With art from: Tang et al. “RNAi-based drug design: considerations and future directions,” Nat Rev Drug Discov. 2024 May ; 23(5): 341–364; in regards to the complexity of using interfering RNA as a therapeutic.
The following discussion will also apply to the limitation, “wherein the protein arginine methyltransferase 9 inhibitor is a…”
Within these 2 claims each individual genus lacks written description, those genera are:
a small interference RNA,
a piwi-interacting RNA,
a microRNA,
a CRISPR Cas guide RNA,
an antisense oligonucleotide,
a small molecule compound, and
an anti- PRMT9 antibody.
Written description for claimed genus may be satisfied through sufficient description of a representative number of species. Starting with the limitation to “a small interference RNA,” the Specification doesn’t describe a single “a small interference RNA” (capable of treating a subject) for inhibition of the PRMT9 gene, stopping the protein being synthesized. Given this is an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus, and here we have no single species disclosed. See Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956 (Fed. Cir. 2002); Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004); Regents of the University of California v. Eli Lilly Co., 119 F.3d 1559 (Fed. Cir. 1997)
Written description is also satisfied when relevant identifying characteristics are disclosed. The Examiner is to determine whether the specification discloses other relevant identifying characteristics sufficient to describe the claimed invention in such full, clear, concise, and exact terms that a skilled artisan would recognize applicant was in possession of the claimed invention. For example, if the art has established a strong correlation between structure and function, one skilled in the art would be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. Thus, the written description requirement may be satisfied through disclosure of function and minimal structure when there is a well-established correlation between structure and function.
The problem here, is that small interfering RNA treatments are quite complex and is a nascent technology, that is unpredictable. This is also a large genus, as several systems are covered by this limitation, ones that use a variety of delivery methods, methods to stabilize the RNA, and methods and techniques to target the cell, in this case the cancer. Applicant has not shown any delivery method, any stabilization strategy, any targeting method, or any other key structure of function. Applicant has simply stated, an interfering RNA to inhibit PRMT9 gene. As such one skilled in the art would not be able to predict with a reasonable degree of confidence the structure of the claimed invention from a recitation of its function. See the MPEP 2163.
The key fact here is that Applicant is claiming the function of inhibiting the PRMT9 gene in a subject with a hematological cancer to treat (efficacy) the subject, moreover in a therapeutically effective amount. All while not providing a single example of this function being performed in the Specification, and the art having no known examples of this function. As such Applicant lacks written description for claim 2.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1 and 2 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barbash WO 2018/100532 A1 published 6/7/2018.
Claim 1 is directed to a method of treating a hematological cancer in a subject in need thereof, the method comprising administering to the subject a therapeutically effective amount of a protein arginine methyltransferase 9 inhibitor.
Barbash teaches treating cancer (claim 12) with a combination of a Type I protein arginine methyltransferase (Type I PRMT) inhibitor and a Type II protein arginine methyltransferase (Type II PRMT) inhibitor (claim 1), wherein the Type II PRMT inhibitor is a protein arginine methyltransferase 9 (PRMT9) inhibitor (claim 3).
Barbash teaches the cancer is lymphoma (a hematological cancer) in claim 29.
Barbash teaches, “ In some embodiments, the Type II PRMT inhibitor is a small molecule compound.”
Claims 1 and 2 are anticipated.
Claim Rejections - 35 USC § 102
Claims 1-2 and 22 are rejected by Crona et al. “A ribonucleotide reductase inhibitor with deoxyribonucleoside-reversible cytotoxicity,” Molecular Oncology 10, (2016) 1375-1386.
Crona teaches the following compound as a drug-like molecule with anti-leukemia activity, see page 1383, column 2, para 2. Crona describes the compound as having distinct activity and one of ordinary skill would at once envisage using the compound as a treatment for leukemia ( a hematological cancer). The compound is a small molecule as required by claim 2. The compounds activity is inherent, as such the inhibition of PRMT9 is derived from the properties of the compound.
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Claims 1, 2, and 22 are anticipated.
Notes
Claims directed to individual compounds (8, 9, and 19) that cannot be derived from the generic/Markush group (claims 6-7, 14-15) would be rejected under 112(b) if under examination. Due to the unclear nature of the genus claimed they cannot be searched. As the limitation required by the genus, not found in the species leads to an open-ended search. It is unclear if the Applicant is claiming those structures or is not claiming them, or if Applicant is claiming a distinct genus not defined by the species or the current Markush Group. Please correct these contradictions.
Conclusion
No claims allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J SCHMITT whose telephone number is (571)270-7047. The examiner can normally be reached M-F 8-6 MidDay Flex.
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/MICHAEL J SCHMITT/Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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